The Effect of Hyperglycaemia on Local Energy Stores in the Working Muscle in Patients With Type 1 Diabetes Mellitus

Insel Gruppe AG, University Hospital Bern

Status: Completed

Conditions: Diabetes Mellitus, Type 1; Exercise

Treatments: Procedure: Normoinsulinemic eu- or hyperglycemic clamp

Study type: Interventional

Funder types: Other

Identifiers

NCT00325559

1122

Details and patient eligibility

About

This study aims at investigating the effect of hyperglycaemia on physical performance and local energy stores in the muscle in patients with type 1 diabetes mellitus under exercise conditions.

Enrollment: 10 estimated patients

Sex: Male

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male
• Aged from 20 to 40 years
• Patients with type 1 diabetes mellitus lasting for at least 5 years (C-Peptide ≤ 0.3 nmol/l in the presence of a plasma glucose level ≥ 7 mmol/L, indicating insulin dependence)
• Insulin delivery by CSII (continuous subcutaneous insulin infusion) for at least 6 months
• Acceptable to good metabolic control, reflected by an HbA1c 5-8%
• Normal insulin sensitivity, reflected by a daily insulin requirement of 0.3-1.0 U/kg body weight
• minimum 30' of moderate exercise 3 times per week
• BMI in the range of 18-25 kg/m2

Exclusion criteria

• Chronic complications of diabetes:

  • Microalbuminuria (Mogensen nephropathy stadium ≥ III)
  • Sensory neuropathy (vibration better than 5/8 at the metatarsophalangeal articulation of digitus I)
  • Proliferating retinopathy
  • No history of macro-vascular complications
  • Clinically relevant autonomous neuropathy

• Smoking

• Abnormal thyroid function

• Major depression, psychosis and other severe personality disorders, claustrophobia

• Active neoplasia

• Contraindications to exposure to a 1.5 T magnetic field (pace-makers, osteosynthetic material, etc.)

• Abnormal liver or renal function (creatinine > 130 µmol/L; ASAT and ALAT > 3 times the upper reference limit)

• Excessive alcohol consumption (>60g/d) or drug-abuse

• Refusal to give written informed consent

• Participation in another study

• Patients, who are not suitable for the study according to the study physician